GTx, Inc. Collaborates with Beckman Coulter Subsidiary to Supply High Grade PIN Samples for Research and Evaluation of Prostate Cancer Markers

Memphis, TN —April 22, 2004—GTx, Inc. (Nasdaq: GTXI) a biopharmaceutical company dedicated to the development and commercialization of therapeutic products for menÍs health, announced today that it has entered into a collaboration with Hybritech, Inc., a wholly owned subsidiary of Beckman Coulter, Inc. Under the terms of the agreement, GTx will provide clinical samples from its Phase IIb clinical trial program evaluating ACAPODENEï for the reduction in the incidence of high grade prostatic intraepithelial neoplasia (PIN), a premalignant lesion that has the potential to progress to prostate cancer. Information resulting from this collaboration will be evaluated for use by Beckman Coulter to determine its usefulness in research, development and evaluation of assays for prostate disease.

"High grade PIN is in the direct causal pathway to prostate cancer," stated Mitchell Steiner, M.D., CEO of GTx. "The development of assays for the accurate detection of PIN could be a component in the treatment of this disease. Together with Beckman Coulter, an innovator in prostate cancer assays, we have the opportunity to develop products that could have a significant impact in the treatment of this deadly disease."

"We are excited to be working with GTx and their carefully documented cohort of PIN samples. PIN may prove to be an important diagnostic indicator since it is considered a progenitor of prostate cancer. This collaboration is a unique opportunity to determine whether our proprietary panel of proPSA serum markers can help diagnose the presence of PIN and the earliest progression to prostate cancer," commented Stephen Mikolajczyk, advanced research scientist for Beckman Coulter.

About high grade PIN
High grade PIN has been established as a premalignant lesion of the prostate that has a high potential to progress to invasive prostate cancer. This year in the United States, approximately 1,300,000 prostate biopsies will be performed to detect over 230,000 new cases of prostate cancer. High grade PIN is found in an average of 9% of prostate biopsies which represents an estimated 115,000 new cases of high grade PIN diagnosed each year. Patients who are found to have high grade PIN are at high risk of prostate cancer with up to 37% of patients being later diagnosed with prostate cancer within 1 year.

Prostate cancer
In the United States, there is estimated to be over 230,000 new prostate cancer cases and 30,000 prostate cancer deaths this year. This makes prostate cancer the most commonly diagnosed cancer and the second leading cause of cancer-related deaths in men in the United States.

High grade PIN clinical development overview
GTx is currently conducting a Phase IIb clinical trial to evaluate its lead product ACAPODENE™ (Toremifene Citrate) tablets for the reduction in the incidence of prostate cancer in men with high grade PIN. Results from a previously conducted open-label, Phase IIa trial of men who had high grade PIN treated with ACAPODENEï showed a greater than 4-fold reduction in this premalignant condition on followup prostate biopsy. ACAPODENEï is a nonsteroidal SERM (selective estrogen receptor modulator) which appears to block the estrogenÍs unwanted actions on the prostate.

About GTx, Inc.
GTx is a biopharmaceutical company dedicated to the discovery, development and commercialization of therapeutics primarily related to the treatment of serious men's health conditions. GTx's drug discovery and development programs are focused on small molecules that selectively modulate the effects of estrogens and androgens. GTx currently has two product candidates that are in human clinical trials. GTx is currently conducting clinical trials on ACAPODENE™, its most advanced product candidate, for two separate indications: (i) a Phase IIb clinical trial to assess the effect of ACAPODENE™ in the reduction in the incidence of prostate cancer in men with precancerous prostate lesions and (ii) a pivotal Phase III clinical trial to assess the effect of ACAPODENE™ in the treatment of serious side effects of androgen deprivation therapy for advanced prostate cancer. GTx is developing its second product candidate, andarine, and other specified backup compounds, with its partner, Ortho Biotech Products, L.P., a subsidiary of Johnson & Johnson. Andarine will be entering a planned Phase II clinical trial this year. GTx retains all rights to the discovery, development, and commercialization of the rest of its SARM program including its other specific product candidates ostarine, prostarine and andromustine.

This press release contains forward-looking statements, including, without limitation, statements related to potential future licensing fees and milestone and royalty payments and GTx's current and anticipated clinical trials and research and development programs. These forward-looking statements are based upon GTx's current expectations. Forward-looking statements involve risks and uncertainties. GTx's actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks that neither GTx nor its partner will be able to commercialize its product candidates if preclinical studies do not produce successful results or clinical trials do not demonstrate safety and efficacy in humans; if third parties do not manufacture the Company's product candidates in sufficient quantities and at an acceptable cost, clinical development and commercialization of its product candidates would be delayed; use of third-party manufacturers may increase the risk that the Company will not have adequate supplies of its product candidates; if third parties on whom the Company relies do not perform as contractually required or expected, the Company may not be able to obtain regulatory approval for or commercialize its product candidates; the Company is dependent upon collaborative arrangements to complete the development and commercialization of some of its product candidates, and these collaborative arrangements may place the development of its product candidates outside its control, may require it to relinquish important rights or may otherwise be on terms unfavorable to the Company; and if the Company is not able to obtain required regulatory approvals, the Company will not be able to commercialize its product candidates. The annual report filed on Form 10”K with the U.S. Securities and Exchange Commission on March 26, 2004 contains under the heading "Additional Factors That Might Affect Future Results" a more comprehensive description of these and other risks to which GTx is subject. GTx expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.